[Edaily Reporter YU JIN-HEE ] Innovative biomedicine company #NEXTBIOMEDICAL CO., LTD. is leading a paradigm shift in the medical device market with “Nexsphere-FTM,” a treatment for knee osteoarthritis developed in-house. Building on successful clinical results achieved in the existing musculoskeletal pain treatment field, the company is expanding into new clinical trials, and Nexsphere-FTM’s platform strategy is expected to gain full momentum.

The Magic of a Temporary Embolization Platform That Blocks Abnormal New Blood Vessels

According to industry sources on the 6th, NEXTBIOMEDICAL CO., LTD. recently partnered with leading UK medical institutions to begin preparations for new clinical trials targeting patients with plantar fasciitis and goiter. The company plans to begin patient recruitment within the third quarter.

The newly added pipeline consists of a clinical trial involving 20 patients with plantar fasciitis in the UK and a clinical trial evaluating the efficacy of thyroid embolization in 10 patients with goiter. If successful, NEXTBIOMEDICAL CO., LTD. will set a record by simultaneously operating a total of 16 comprehensive clinical trial programs (covering knee osteoarthritis, patellar tendinitis, wrist and elbow conditions, musculoskeletal disorders, etc.) in the global market.

At the center of this new clinical trial is NexSphere-F, an “intravascular embolization-promoting implant” that temporarily blocks abnormally grown microvessels to innovatively reduce pain. Simply put, when chronic arthritis or inflammation occurs in the body, abnormal “new blood vessels” (neovessels) grow at the site of the lesion. These harmful blood vessels are not merely tissues that supply blood; they are the primary culprits that stimulate nerves, sending signals of extreme pain to the brain and triggering chronic inflammation. NexSphere-F works by precisely targeting these pain-inducing blood vessels and temporarily blocking blood flow with microscopic spherical particles, thereby alleviating pain.

Most embolization products previously used in the medical field were developed using non-biodegradable materials that permanently block blood vessels. While this may be effective for treating tumors, where it is necessary to cut off the blood supply to cancer cells, However, using permanent occlusion products for musculoskeletal conditions such as arthritis or tendon inflammation has clear limitations, as they prevent blood from circulating to surrounding healthy tissue, leading to side effects such as tissue death (necrosis) or skin discoloration.

In contrast, NexSphere-F has the unique advantage of regulating blood flow to the site of pain for a certain period after being injected into the body, then naturally dissolving and disappearing. Because it safely degrades inside the body, it minimizes damage to surrounding healthy tissue; after managing the initial inflammatory pain, the blood vessels naturally reopen, promoting normal tissue recovery. This is why leading medical experts have heaped praise on it, hailing it as a completely new therapeutic approach that goes beyond simply blocking blood vessels.

Conditions such as arthritis, tendinopathy (tendon disease), frozen shoulder, and sports injuries—which appear to be distinct ailments affecting entirely different parts of the body—all share a common denominator from a molecular medicine perspective. NexSphere-F adopts a “common pathophysiology-based platform strategy” that simultaneously breaks these four key links, enabling the innovation of treating countless diseases at once with a single product.

Having already demonstrated solid efficacy and safety in the treatment of knee osteoarthritis, NexSphere-F is currently accumulating real-world clinical evidence and publishing papers in leading international journals across various indications. Clinical results are pouring in, showing that the treatment goes beyond the simple proof-of-concept stage to deliver outstanding therapeutic effects for actual patients. In fact, the results of a retrospective analysis conducted at the prestigious Charité Berlin Hospital in Germany took the global medical community by surprise. A 12-month long-term follow-up study involving 41 elderly patients with hip osteoarthritis—who had failed to respond to conventional injections or drug therapies and were scheduled for surgery—revealed that the success rate of embolization procedures using NexSphere-F reached 97.5%. The procedure also demonstrated its safety, as not a single case of serious adverse effects or avascular necrosis of the femoral head—a condition where bone tissue dies—occurred post-procedure.

Patients’ subjective pain scores also decreased significantly, from an average of 7—indicating severe pain—before the procedure to 4 afterward. Hip function assessment indicators also showed remarkable improvement across all areas. Most notably, the rate of patients progressing to total hip arthroplasty (THA)—a major surgery involving the complete replacement of the artificial joint—was a mere 4.9% even one year after the procedure. This demonstrates the potential to delay the need for joint replacement surgery, which involves significant physical strain and a long recovery period, by several years.

A Race for Global Market Share... Targeting 100 Billion Won in Sales Within 5 Years

NEXTBIOMEDICAL CO., LTD. is building a strong foundation of clinical and real-world evidence based on large-scale patient data from over 1,500 patients worldwide. In South Korea, patient recruitment has already been completed at Severance Hospital (knee joints) and Konkuk University Hospital (wrists and elbows). Recruitment is also progressing smoothly at Seoul National University Hospital and Chung-Ang University Hospital, with 70% and 30% of patients enrolled, respectively. The company’s efforts on the global stage are far more aggressive. The clinical trial for degenerative knee osteoarthritis in Europe has already surpassed a 65% patient enrollment rate and is moving toward the final stages of commercialization. In the United States, the world’s largest market, a clinical trial for U.S. Food and Drug Administration (FDA) approval—involving more than 15 leading medical institutions—has entered full swing.

In particular, the company achieved the remarkable feat of obtaining “Category B” approval from the U.S. Centers for Medicare & Medicaid Services (CMS), which allows it to receive direct reimbursement for new clinical trial costs through local health insurance. This has enabled the company to significantly reduce costs while gaining a competitive edge in the race for global commercialization. Furthermore, the company was selected as a recipient of support for overseas clinical trials by the Inter-Ministerial Medical Device R&D Project Group, a government-affiliated organization, thereby securing a large-scale government grant totaling 2.2 billion won to fund the FDA-approval clinical trials.

The company has also completed the establishment of a global distribution network. By signing an exclusive distribution agreement with the European subsidiary of Terumo, a global medical device company, targeting Europe, the Middle East, and select countries in Africa, the company is accelerating its penetration of these local markets. To capture the Japanese market as well, it has secured an exclusive local distribution agreement with Asahi Intech LTD., which possesses a global network in the local guidewire and catheter sectors.

Another key pillar supporting NEXTBIOMEDICAL CO., LTD.’s rapid growth is “Nexpowder™,” an endoscopic hemostatic agent that has already secured a leading market position. Through Medtronic, the world’s leading medical device company, it serves as a reliable cash cow, generating more than 90% of global sales overseas in U.S. dollars. Not stopping there, the company is accelerating the development of “Nexpowder-T,” a next-generation convergent product that perfectly combines adhesive properties—which allow it to physically adhere to wound sites—with a chemical blood coagulation mechanism, through a government-funded project by the Ministry of SMEs and Startups, bringing its designation as a global standard treatment one step closer.

The outlook from the investment industry and capital markets is also very bright. According to the financial investment industry, NEXTBIOMEDICAL CO., LTD.’s annual revenue this year is virtually certain to surpass the 25 billion won mark for the first time in its history. The company aims to usher in an era of 100 billion won in annual revenue within five years by establishing NexSphere-F as a platform.

Hong Soon-jae, CEO of BioBook, commented, “NEXTBIOMEDICAL CO., LTD. is rapidly accumulating concrete clinical results centered on NexSphere-F that medical professionals worldwide can trust.” He added, “Transforming it into a medical platform that treats the common principles of inflammation within the body—rather than a one-time device that simply cures a single disease—will contribute to enhancing the company’s value.”